Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-27 @ 6:16 AM
Study NCT ID:
NCT07012850
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-10
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced Magnetic Resonance Imaging for Perioperative Evaluation of Dental, Oral and Maxillofacial Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008446', 'term': 'Maxillofacial Injuries'}], 'ancestors': [{'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'qualitative imaging parameters', 'timeFrame': 'From enrollment to the end of treatment at week 5', 'description': 'Primary Outcome Measures:\n\n1\\. Qualitative Assessment of Imaging Quality\n\nDescription: Image quality will be evaluated using a standardized 5-point Likert scale for the following parameters: overall image quality, artifact severity, fracture visibility, and bone-to-soft-tissue contrast. Each parameter will be scored independently.\n\nUnit of Measure: Score on a 5-point Likert scale (1 = poor, 5 = excellent)'}, {'measure': 'Quantitative Assessment of Fracture Dimensions', 'timeFrame': 'From enrollment to the end of treatment at week 5', 'description': 'Fracture length, width, and depth will be measured in millimeters across axial, sagittal, and coronal planes using standardized digital radiologic tools. Measurements will be taken by two blinded radiologists and averaged.\n\nUnit of Measure: Millimeters (mm).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatology', 'Maxillofacial Trauma', 'Maxillofacial Injuries']}, 'descriptionModule': {'briefSummary': "Dental, oral, and maxillofacial trauma represents a significant public health concern, with most cases resulting from accidents and occurring frequently in young adults. Diagnosis relies on clinical examination and imaging modalities like computed tomography (CT) and cone-beam computed tomography (CBCT), which are standard for hard tissue assessment but expose patients to ionizing radiation. To reduce radiation exposure while simultaneously allowing for the visualization of soft tissues, newer imaging methods, including magnetic resonance imaging (MRI), as well as Black Bone and CT-like MRI protocols (ZTE, UTE), are being explored. These MRI techniques offer high-resolution, non-ionizing alternatives, showing promise for diagnosing soft tissue injuries and fractures without radiation risks, especially beneficial for younger patients. This study aims to assess MRI's diagnostic capabilities for maxillofacial trauma, focusing on early diagnosis, artifact reduction, and comparison to conventional X-ray-based imaging, within a minimal-risk study framework.\n\nThis study aims to evaluate the diagnostic efficacy of MRI compared to X-ray-based imaging modalities (CT/CBCT) for detecting dental, oral, and maxillofacial fractures, with a specific focus on Black Bone and CT-like MRI techniques. Additionally, it investigates MRI's potential to reduce artifacts around osteosynthesis plates, enhancing postoperative imaging quality in the presence of metal hardware."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study Population from the University Hospital Zurich, Switzerland', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with acute dental, oral and maxillofacial trauma\n* Age: 18 years and older\n* Able to give informed consent (documented by signature)\n* No prior radiation-based imaging for the current trauma episode\n\nExclusion Criteria:\n\n* Pregnant or lactating individuals\n* Known contraindications to MRI (e.g., pacemakers, certain implants)\n* Clinically significant concomitant diseases affecting imaging quality (e.g., severe neurocognitive disorders)\n* Inability to comply with MRI procedures or study protocol (e.g., due to language barriers, psychological disorders, or dementia)\n* Participation in other clinical trials that may interfere with the imaging study'}, 'identificationModule': {'nctId': 'NCT07012850', 'briefTitle': 'Advanced Magnetic Resonance Imaging for Perioperative Evaluation of Dental, Oral and Maxillofacial Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Advanced Magnetic Resonance Imaging for Perioperative Evaluation of Dental, Oral and Maxillofacial Trauma', 'orgStudyIdInfo': {'id': '2024-02307'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'To reduce radiation exposure while simultaneously allowing for the visualization of soft tissues, newer imaging methods, including magnetic resonance imaging (MRI), as well as Black Bone and CT-like MRI protocols (ZTE, UTE), are being explored. These MRI techniques offer high-resolution, non-ionizing alternatives, showing promise for diagnosing soft tissue injuries and fractures without radiation risks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Department of Cranio-Maxillofacial and Oral Surgery, University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harald Essig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Dr. med. dent.', 'investigatorFullName': 'Harald Essig', 'investigatorAffiliation': 'University of Zurich'}}}}